ClinicalTrials.gg
CompletedNCT03269825Updated Feb 15, 2019

The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO

An observational study in Critical Illness and Muscle Atrophy, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Primary conditionMuscular AtrophyRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Muscular Atrophy
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Muscular Atrophy.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
215
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Muscular Atrophy with a site in United Kingdom — 7 open to participants now, 11 under way, 2 of them phase 3. Muscular Atrophy · United Kingdom.

Enrollment
Largest of 10
215 · median 29
Started
2017
with 6 others
Observational
10 of 52
1 open now
Registered
18th of 52
by date
Lead sponsor
2 of 52
Guy's and St Thomas' NHS Foundation Trust

Among the 52 studies in Muscular Atrophy with a site in United Kingdom, this one has the largest enrollment of the 10 observational ones that give a count, is one of 7 that started in 2017, is one of 10 observational ones, and was the 18th registered.

Muscular Atrophy

413 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

Browse Muscular Atrophy studies →

Open to participants now

7 of the 52 studies in Muscular Atrophy with a site in United Kingdom are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 51 Muscular Atrophy studies recruiting now, 25 (49%) set no upper age limit and 12 (24%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 52 studies in Muscular Atrophy with a site in United Kingdom, or all of them as a file.
02

Study summary

This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).

Read the detailed description

The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.

Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.

03

Conditions studied

  • Critical Illness
  • Muscle Atrophy

Browse trials for

04

In context

Muscular Atrophy Reclassified

413 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

This study's enrollment of 215 is above the median of 61 across 73 observational studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.

Compared within Muscular Atrophy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult Critically ill patients with severe respiratory failure requiring VV-ECMO

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen

Exclusion criteria

Exclusion Criteria:

  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
  • Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software
06

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
215 participants (actual)
Patient registry
No
07

What researchers measure

Primary outcomes

  1. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: On ECMO (expected to be about 10 days)

Secondary outcomes

  1. Length of ECMO duration

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: The total duration on ECMO (expected to be an average of 10 days)

  2. Length of ICU admission

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: The total duration of ICU admission (expected to be around 2 weeks)

  3. Length of hospital stay

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: The total duration of hospital admission (expected to be around 28 days)

  4. Length of ventilation

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)

  5. Discharge destination

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: After discharge from hospital (expected to be around 28 days)

  6. Sequential changes in the muscle quantity over time

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Time frame: The total duration of ECMO (expected to be around 10 days)

  7. Sequential changes in muscle quality over time

    Using total muscle quality measured from CT slice of the third lumbar region.

    Time frame: The total duration of ECMO (expected to be around 10 days)

  8. Relationship between muscle loss and total nutrition received

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Time frame: The total duration of ECMO (expected to be around 10 days)

  9. Relationship between muscle loss and rehabilitation goals met

    Using total muscle quantity measured from CT slice of the third lumbar region.

    Time frame: The total duration of ECMO (expected to be around 10 days)

  10. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: Intensive Care Unit Stay (expected to be about 2 weeks)

  11. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: 6 months post-ICU discharge

  12. All cause mortality

    Using total muscle quantity and quality measured from CT slice of the third lumbar region.

    Time frame: Hospital discharge (expected to be about 28 days)

08

Study locations

1 site
  • Guy's and St Thomas' NHS Foundation Trust
    London, SE1 7EH, United Kingdom
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in May 2018, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2017
First posted
Sep 1, 2017
StartActual
Jun 20, 2017
Primary completionActual
May 31, 2018
CompletionActual
May 31, 2018
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03269825
Responsible party
Danielle Bear (HEE / NIHR Clinical Doctoral Fellow and Critical Care Dietitian, Guy's and St Thomas' NHS Foundation Trust) — Principal investigator
First posted
Sep 1, 2017
Start date
Jun 20, 2017
Primary completion
May 31, 2018
Completion
May 31, 2018
Last update
Feb 15, 2019

Study contacts

Danielle E Bear, MRes
principal investigator · Guy's and St Thomas' NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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